Express Pharma

Lupin gets US FDA nod for generic drug

The product is the generic equivalent of Vertex Pharma's Kalydeco tablets and will be manufactured at the company's Nagpur facility

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Lupin said it has received tentative approval from the US health regulator to market Ivacaftor tablets, used to treat cystic fibrosis, in America.

The company has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ivacaftor tablets, 150 mg strength, Lupin said in a statement.

The product is the generic equivalent of Vertex Pharma’s Kalydeco tablets and will be manufactured at the company’s Nagpur facility.

Edits by EP News Bureau

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